BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4093145 · Received September 10, 2014

    Report

    Report Number
    1219930-2014-00803
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 21, 2014
    Manufacturer
    COVIDIEN FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ESOPHAGECTOMY. ACCORDING TO THE REPORTER: AT THE 4TH REPLACEMENT OF THE SULU, IT COULD NOT BE LOADED PROPERLY AND THE DEVICE COULD NOT FIRE. THEN BOTH THE BATTERY AND ADAPTER WERE RESET WITH THE DEVICE AND ANOTHER SULU WAS LOADED TO TRY AGAIN. THEN THE FOLLOWING FAILURE OCCURRED" WHILE KEEPING THE BLUE BUTTON PUSHED FOR A WHILE, A DOCTOR FOUND THE CARTRIDGE KNIFE STARTED TO BE CLOSED. AT THE LAST MOMENT BEFORE IT WAS CLOSED COMPLETELY, THE CARTRIDGE AUTOMATICALLY ROTATED TO THE LEFT AND IT CLAMPED. THE JAWS LOCKED ON THE TISSUE, HOWEVER, THERE WAS NO TISSUE DAMAGE DURING RELEASE OF THE JAWS FROM THE TISSUE. OPERATING TIME WAS NOT EXTENDED. IT IS UNK WHETHER REINFORCEMENT MATERIAL WAS USED. THE LAST KNOWN PT STATUS WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559614 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN FORMERLY US SURGICAL N3J1468UX

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO GIA ADAPTER STANDARD, EGIAADAPT,| MFG DATE: 10/2013, K121510| SERIAL NO: (B)(4), LOT NO: N3K0823UX,